Clinical Data Specialist in Rockville, Maryland at Capital Technology Information Services

Clinical Data Specialist – FDA DMDQ

Functional / Business Analyst – Expert | SEND / Nonclinical SME + Data Operations

Company: CTIS
Employment Type: This position is contingent upon contract award and funding. The anticipated start date will be confirmed following award.

Position Overview

CTIS is seeking an experienced Clinical Data Specialist / Functional Business Analyst – Expert to support FDA CDER/OCS study data management and data quality activities. The ideal candidate will have hands-on experience with clinical study data processing, validation, loading, curation, and issue resolution, along with strong knowledge of FDA regulatory data requirements and CDISC standards.

Experience with SEND and nonclinical study data is highly preferred.

Key Responsibilities

• Process, validate, load, and curate clinical study datasets.
• Review study data for quality, completeness, consistency, and FDA/CDISC conformance.
• Apply CDISC standards, including SDTM and ADaM; SEND knowledge is preferred.
• Identify, investigate, and resolve data quality issues and validation errors.
• Apply FDA study-data guidance, business rules, and validation requirements.
• Support data-quality reporting, issue tracking, root-cause analysis, and remediation.
• Perform data review and validation using SQL, SAS, and/or other data management and validation tools.
• Support data operations and ensure accurate and timely processing of study data.
• Collaborate with clinical, data management, data quality, statistical, and technical teams.
• Provide functional expertise related to clinical and regulatory data management activities.

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Biostatistics, Computer Science, Health Informatics, or a related field.
• Hands-on experience in clinical study data management, data operations, or regulatory data.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Experience with data validation, curation, quality review, and issue resolution.
• Experience with SQL, SAS, or similar data analysis and validation tools.
• Strong analytical, problem-solving, communication, and collaboration skills.

Preferred Qualifications

• Experience supporting FDA CDER/OCS programs.
• Experience with SEND and nonclinical study data.
• Current or recent FDA access/credentials.
• Ability to begin onboarding promptly upon contract award
• Recent U.S. residency history, preferably having lived in the United States for at least 3 of the past 5 years.
• Knowledge of FDA study-data guidance and validation requirements.
• Functional/business analysis experience within clinical, regulatory, or life sciences data environments.
• Experience working with data management and data quality teams.
• Familiarity with FDA data standards, regulatory submissions, and clinical study datasets.

Work Environment

This role supports a mission-critical FDA data management and quality initiative and requires the ability to work effectively with cross-functional teams in a regulated, data-intensive environment. This position is contingent upon contract award and funding. The anticipated start date will be confirmed following award.